Cytocell Recalls Aquarius CRLF2 Distal Probe Due to Faint Signal Risk
Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green because faint additional signals may cause normal samples to be misreported as abnormal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states there is a 'low risk' of misreporting and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A. The affected lots are 072240, 071390, and 072693. The product was distributed domestically to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington, as well as to Canada.
The recall is due to the potential for users to observe very faint additional locus-specific signals at 11q13. This issue creates a low risk that a normal sample may be incorrectly reported as not normal in a resulting laboratory developed test (LDT) that utilizes the probe.
Users of the affected probes should contact Cytocell Ltd. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
- Manufacturer
- Cytocell Ltd.
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots 072240
- 071390
- and 072693
Distribution
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